Negative pressure treatment system with heating and cooling provision

ABSTRACT

A method, and apparatus for the controlled acceleration, and/or retardation of the body&#39;s inflammatory response generally comprises a foam pad for insertion substantially into a wound site, a heating, a cooling pad for application over the wound site, a wound drape or sealing enclosure of the foam pad, the heating, and cooling pad at wound site The foam pad is placed in fluid communication with a vacuum source for promotion of the controlled acceleration or retardation of the body&#39;s inflammatory response. The heating, and cooling provision controls the local metabolic function as part of the inflammatory response.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/475,002 filed May 29, 2009, which is a divisional of U.S. patentapplication Ser. No. 11/545,142, filed Oct. 10, 2006, now U.S. Pat. No.7,540,848 issued Jun. 2, 2009 which is a continuation of U.S. patentapplication Ser. No. 09/937,937, filed Oct. 2, 2001, now U.S. Pat. No.7,144,390 issued Dec. 5, 2006, which is a national stage application ofInternational Application No. PCT/US00/08759, filed Mar. 31, 2000, whichclaims the benefit of U.S. Provisional Application No. 60/127,596, filedAp. 2, 1999. All of the above-referenced applications are herebyincorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to the healing of wounds. Morespecifically, the present invention relates to the vacuum assistedclosure of wounds wherein localized heating or cooling is used toaccelerate or retard the metabolic function of the inflammatory systemin order to facilitate wound healing.

2. Description of Related Art

Wound closure involves the inward migration of epithelial andsubcutaneous tissue adjacent the wound. This migration is ordinarilyassisted through the inflammatory process, whereby blood flow isincreased and various functional cell types are activated. Through theinflammatory process, blood flow through damaged or broken vessels isstopped by capillary level occlusion, whereafter cleanup and rebuildingoperations may begin. Unfortunately, this process is hampered when awound is large or has become infected. In such wounds, a zone of stasis(i.e. an area in which localized swelling of tissue restricts the flowof blood to the tissues) forms near the surface of the wound.

Without sufficient blood flow, the epithelial and subcutaneous tissuessurrounding the wound not only receive diminished oxygen and nutrients,but are also less able to successfully fight bacterial infection andthus are less able to naturally close the wound. Until recently, suchdifficult wounds were addressed only through the use of sutures orstaples.

Although still widely practiced and often effective, such mechanicalclosure techniques suffer a major disadvantage in that they producetension on the skin tissue adjacent the wound. In particular, thetensile force required in order to achieve closure using sutures orstaples causes very high localized stresses at the suture or stapleinsertion point. These stresses commonly result in the rupture of thetissue at the insertion points, which can eventually cause wounddehiscence and additional tissue loss.

Additionally, some wounds harden and inflame to such a degree due toinfection that closure by stapling or suturing is not feasible. Woundsnot reparable by suturing or stapling generally require prolongedhospitalization, with its attendant high cost, and major surgicalprocedures, such as grafts of surrounding tissues. Examples of woundsnot readily treatable with staples or suturing include large, deep, openwounds; decubitus ulcers; ulcers resulting from chronic osteomyelitis;and partial thickness burns that subsequently develop into fullthickness burns.

As a result of these and other shortcomings of mechanical closuredevices, methods and apparatus for draining wounds by applyingcontinuous negative pressures have been developed. When applied over asufficient area of the wound, such negative pressures have been found topromote the migration toward the wound of epithelial and subcutaneoustissues. In practice, the application to a wound of negative pressure,commonly referred to as vacuum assisted closure (VAC) therapy, typicallyinvolves mechanical-like contraction of the wound with simultaneousremoval of excess fluid. In this manner, applying negative pressureaugments the body's natural inflammatory process while alleviating manyof the known intrinsic side effects, such as the production of edemacaused by increased blood flow absent the necessary vascular structurefor proper venous return.

While applying negative pressure has been highly successful in thepromotion of wound closure, healing many wounds previously thoughtlargely untreatable, some difficulty remains. Because the inflammatoryprocess is very unique to the individual patient, even the addition ofnegative pressure does not result in a fast enough response for closureof some wounds, especially when applied during the occlusion and initialcleanup and rebuilding stages. It is therefore a principle object of thepresent invention to provide a method and apparatus whereby the knownnegative pressure modalities are improved through controlledacceleration of the inflammatory response.

Additionally, and again at least partially attributable to the variancebetween patients, it is possible that a properly initiated inflammatoryresponse may be taken too far, resulting in edema and pain. It istherefore another principle object of the present invention to provide amethod and apparatus whereby the known negative pressure modalities areimproved through controlled retardation of the inflammatory response.

SUMMARY

In accordance with the foregoing objects, the present invention—a methodand apparatus for the controlled acceleration and/or retardation of thebody's inflammatory response—generally comprises a foam pad forinsertion substantially into a wound site, a heating and cooling pad forapplication over the wound site and a wound drape for sealing enclosureof the foam pad and the heating and cooling pad at the wound site.According to the invention, the foam pad is placed in fluidcommunication with a vacuum source for promotion of fluid drainage whilewarm or cool fluid is circulated through the heating and cooling pad forthe controlled acceleration or retardation, respectively, of themetabolic function portion of the body's inflammatory response.

According to the preferred embodiment of the present invention, aheating and cooling provision is added to the previously knownapplication of negative pressure to control the local metabolic functionas part of the inflammatory response. By providing localized heating incombination with the otherwise ordinary application of negativepressure, the overall inflammatory response can be synergisticallyaccelerated to produce rapid capillary occlusion and earlier initiationof the cleanup and rebuilding stages. Likewise, in the event that theattending clinician determines that the inflammatory response has beenover-activated, localized cooling may be provided in combination withthe application of negative pressure to retard the body's inflammatoryresponse without sacrifice of the edema control and other aspects of theotherwise provided negative pressure.

In the preferred embodiment of the present invention, the heating andcooling pad comprises a flexible and breathable water layer, generallycomprising two sheets of RF-weldable material. The two sheets of the padare RF-welded together in a waffle-like pattern, wherein a plurality ofapertures is formed between a plurality of channels. The apertures allowthe transpiration of moisture from the patient's skin while the channelsallow the circulation, via a supply tube and a drainage tube, of warm orcool water, as required, through the pad for the heating or coolingthereof.

While the heating and cooling pad may be placed inside or outside of thewound drape during the heating aspect of the present invention, it iscritical that the heating and cooling pad be placed inside of the wounddrape during the cooling aspect of the present invention. In thismanner, condensate formation on the interior of the drape, which maycause the drape's adhesive to loosen and ultimately result in loss ofvacuum at the wound site, can be minimized. In particular, placing theheating and cooling pad inside the wound drape limits the surroundingmoisture content to that existing and generated within the confines ofthe wound site, which is minimized by the suction aspect of the negativepressure.

Because the cooling aspect of the present invention should beimplemented in this manner and the clinician may indicate the need forcooling at any time after initiation of the application of negativepressure, the preferred method of the present invention comprisesplacing the heating and cooling pad beneath the wound drape, adjacentthe foam pad and wound site, regardless of whether heating or cooling isinitially indicated. Upon placement of the pad, the wound drape isfirmly adhered about the supply tube and drainage tube to prevent vacuumleakage.

Finally, many other features, objects and advantages of the presentinvention will be apparent to those of ordinary skill in relevant arts,especially in light of the foregoing discussions, the following drawingsand exemplary detailed description and the claims appended hereto.

BRIEF DESCRIPTION OF THE DRAWINGS

Although the scope of the present invention is much broader than anyparticular embodiment, a detailed description of the preferredembodiment follows together with illustrative figures, wherein likereference numerals refer to like components, and wherein:

FIG. 1 shows, in partially cut away perspective view, the preferredembodiment of the present invention as applied to a mammalian woundsite.

FIG. 2 shows, in top cross-sectional plan view, the heating and coolingpad of the invention of FIG. 1.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Although those of ordinary skill in the art will readily recognize manyalternative embodiments, especially in light of the illustrationsprovided herein, this detailed description is exemplary of the preferredembodiment of the present invention—a vacuum assisted closure systemwith heating and cooling provision, the scope of which is limited onlyby the claims appended hereto.

Referring now to the figures, the present invention 10 is shown to,generally comprise a foam pad 11 for insertion substantially into awound site 12, a heating and cooling pad 13 for application over thewound site 12 and a wound drape 14 for sealing enclosure of the foam pad11 and the heating and cooling pad 13 at the wound site 12. According tothe invention, the foam pad 11 is placed in fluid communication with avacuum source for promotion of fluid drainage while warm or cool fluidis circulated through the heating and cooling pad 13 for the controlledacceleration or retardation, respectively, of the metabolic functionportion of the body's inflammatory response.

According to the preferred embodiment of the present invention, the foampad 11, wound drape 14 and vacuum source are implemented as known in theprior art, each of which is detailed in U.S. patent application Ser. No.08/517,901 filed Aug. 22,1995. By this reference, the full disclosure ofU.S. patent application Ser. No. 08/517,901 (“the '901 application”),including the claims and the drawings, is incorporated herein as thoughnow set forth in its entirety. Additionally, such a negative pressuresystem is readily commercially available through Kinetic Concepts, Inc.of San Antonio, Tex., U.S.A. and/or its subsidiary companies.

As detailed in the '901 application, the foam pad 11 preferablycomprises a highly reticulated, open-cell polyurethane or polyether foamfor good permeability of wound fluids while under suction. As alsodetailed in the '901 application, the foam pad 11 is preferably placedin fluid communication, via a plastic or like material hose 15, with avacuum source, which preferably comprises a canister safely placed undervacuum through fluid communication, via an interposed hydrophobicmembrane filter, with a vacuum pump. Finally, the '901 application alsodetails the wound drape 14, which preferably comprises an elastomericmaterial at least peripherally covered with a pressure sensitive,acrylic adhesive for sealing application over the wound site 12.

According to the preferred method of the present invention, thosecomponents as are described in the '901 application are generallyemployed as known in the art with the exception that the heating andcooling provision of the present invention is added to control the localmetabolic function as part of the inflammatory response. By providinglocalized heating in combination with the otherwise ordinary applicationof negative pressure, the overall inflammatory response can besynergistically accelerated to produce rapid capillary occlusion andearlier initiation of the cleanup and rebuilding stages. Likewise, inthe event that the attending clinician determines that the inflammatoryresponse has been over-activated, localized cooling may be provided incombination with the application of negative pressure to retard thebody's inflammatory response without sacrifice of the edema control andother aspects of the otherwise provided negative pressure.

In the preferred embodiment of the present invention, the heating andcooling pad 13 comprises a flexible and breathable water layer 16,generally comprising two sheets 17 (one not shown) of RF-weldablematerial. The two sheets 17 of the pad are RF-welded together in awaffle-like pattern, wherein a plurality of apertures 19 is formedbetween a plurality of channels 20. The apertures 19 allow thetranspiration of moisture from the patient's skin 21 while the channels20 allow the circulation, via a supply tube 22 and a drainage tube 23,of warm or cool water, as required, through the pad 13 for the heatingor cooling thereof.

While the heating and cooling pad 13 may be placed inside or outside ofthe wound drape 14 during the heating aspect of the present invention,it is critical that the heating and cooling pad 13 be placed inside ofthe wound drape 14 during the cooling aspect of the present invention.In this manner, condensate formation on the interior and near the edgesof the drape 14, which may cause the drape's adhesive to loosen andultimately result in loss of vacuum at the wound site 12, can beminimized. In particular, placing the heating and cooling pad 13 insidethe wound drape 14 limits the surrounding moisture content to thatmoisture level existing and generated within the confines of the woundsite 12, which is minimized by the suction aspect of the negativepressure.

Because the cooling aspect of the present invention should beimplemented in this manner and the clinician may indicate the need forcooling at any time after initiation of the application of negativepressure, the preferred method of the present invention comprisesplacing the heating and cooling pad 13 beneath the wound drape 14,adjacent the foam pad 11 and wound site 12, regardless of whetherheating or cooling is initially indicated. Upon placement of the pad 13,the wound drape 14 is firmly adhered about the supply tube 22 and thedrainage tube 23 to prevent vacuum leakage.

While the foregoing description is exemplary of the preferred embodimentof the present invention, those of ordinary skill in the relevant artswill recognize the many variations, alterations, modifications,substitutions and the like as are readily possible, especially in lightof this description, the accompanying drawings and the claims drawnhereto. For example, those of ordinary skill in the art will recognizethat the heating and cooling pad 13 may be constructed in a wide varietyof shapes, sizes and internal structures. Such an alternative embodimentmay comprise the integration of the heating and cooling pad 13 into amulti-layered version of the wound drape 14. In any case, because thescope of the present invention is much broader than any particularembodiment, the foregoing detailed description should not be construedas a limitation of the present invention, which is limited only by theclaims appended hereto.

1-50. (canceled)
 51. An apparatus for controlling blood flow throughdamaged tissue, comprising: a porous pad configured to be placedproximate the damage tissue and adapted to be fluidly coupled to asource of negative pressure for providing a vacuum proximate the damagedtissue; a drape having an adhesive adapted to form an enclosure forsealing the porous pad to maintain a vacuum proximate the damagedtissue; and a thermal control element configured to be placed proximatethe damaged tissue, the thermal control element having a pair offlexible sheets connected to form at least one fluid channel between thesheets to receive a circulated fluid, the thermal control elementfurther including at least one aperture passing through the sheets toallow transpiration of moisture through the sheets.
 52. The apparatusaccording to claim 51, wherein the at least one fluid channel receivesthe circulated fluid at a temperature greater than the temperatureproximate the damaged tissue.
 53. The apparatus according to claim 52,wherein the circulated fluid is water.
 54. The apparatus according toclaim 51, wherein the at least one fluid channel receives the circulatedfluid at a temperature less than the temperature proximate the damagedtissue.
 55. The apparatus according to claim 54, wherein the circulatedfluid is water.
 56. The apparatus according to claim 51, wherein thethermal control element is placed in contact with the porous pad beneaththe drape.
 57. The apparatus according to claim 51, wherein the thermalcontrol element is placed in contact with the porous pad beneath thedrape, and the at least one fluid channel receives the circulated fluidat a temperature greater than the temperature proximate the damagedtissue.
 58. The apparatus according to claim 51, wherein the thermalcontrol element is placed in contact with the porous pad beneath thedrape, and the at least one fluid channel receives the circulated fluidat a temperature less than the temperature proximate the damaged tissue.59. The apparatus according to claim 51, wherein the drape is disposedbetween the thermal control element and the porous pad.
 60. Theapparatus according to claim 51, wherein the drape is disposed betweenthe thermal control element and the porous pad, and the at least onefluid channel receives the circulated fluid at a temperature greaterthan the temperature proximate the damaged tissue.
 61. The apparatusaccording to claim 51, wherein the pair of sheets is connected by RFwelds.
 62. An apparatus for controlling blood flow through damagedtissue, comprising: a porous pad configured to be placed proximate thedamaged tissue and adapted to be fluidly coupled to a source of negativepressure for providing a vacuum proximate the damaged tissue; a drapeadapted to form an enclosure for sealing the porous pad to maintain avacuum proximate the damaged tissue; and a heating element placedproximate the damaged tissue and having a breathable water layer havingfluid channels and apertures between the fluid channels.
 63. Theapparatus according to claim 62, wherein the heating element is placedin contact with the porous pad.
 64. The apparatus according to claim 62,wherein the drape has an adhesive for sealing the porous pad proximatethe damaged tissue.
 65. The apparatus according to claim 62, wherein thedrape is disposed between the heating element and the porous pad. 66.The apparatus according to claim 62, wherein the breathable water layerfurther comprises a first sheet connected to a second sheet to form thefluid channels.
 67. The apparatus according to claim 66, wherein thefirst and second sheets are flexible.
 68. The apparatus according toclaim 62, wherein the fluid channels are continuous.
 69. The apparatusaccording to claim 62, wherein the fluid channels include an inletconfigured for connection to a supply tube and an outlet configured forconnection to a drainage tube.
 70. The apparatus according to claim 62,wherein the breathable water layer further comprises a first sheetconnected to a second sheet to form the fluid channels, and wherein thefluid channels are continuous and include an inlet configured forconnection to a supply tube and an outlet configured for connection to adrainage tube.
 71. The apparatus according to claim 62, wherein thefluid channels receive a circulating fluid at a temperature greater thanthe temperature proximate the damaged tissue.
 72. The apparatusaccording to claim 62, wherein the heating element further comprises acooling element.
 73. The apparatus according to claim 62, wherein theheating element further comprises a cooling element, and the fluidchannels receive a circulating fluid at a temperature less than thetemperature proximate the damaged tissue.
 74. An apparatus forcontrolling blood flow through damaged tissue, comprising: a porous padconfigured to be placed proximate the damaged tissue and adapted to befluidly coupled to a source of negative pressure for providing a vacuumproximate the damaged tissue; a drape adapted to form an enclosure forsealing the porous pad to maintain a vacuum proximate the damagedtissue; and a cooling element in contact with the porous pad and havinga breathable water layer having fluid channels and apertures between thefluid channels.
 75. The apparatus according to claim 74, wherein in thedrape has an adhesive for sealing the porous pad proximate the damagedtissue.
 76. The apparatus according to claim 74, wherein the breathablewater layer further comprises a first sheet connected to a second sheetto form the fluid channels.
 77. The apparatus according to claim 74,wherein the fluid channels are continuous.
 78. The apparatus accordingto claim 74, wherein the fluid channels include an inlet configured forconnection to a supply tube and an outlet configured for connection to adrainage tube.
 79. The apparatus according to claim 74, wherein thebreathable water layer further comprises a first sheet connected to asecond sheet to form the fluid channels, and wherein the fluid channelsare continuous and include an inlet configured for connection to asupply tube and an outlet configured for connection to a drainage tube.80. The apparatus according to claim 74, wherein the fluid channelsreceive a circulating fluid at a temperature less than the temperatureproximate the damaged tissue.
 81. A method for controlling blood flowthrough damaged tissue, comprising: securing a porous pad and abreathable layer in a sealed environment proximate the damaged tissue;maintaining a vacuum in the sealed environment; circulating a fluidthrough fluid channels in the breathable layer while transportingmoisture away from the sealed environment through apertures in thebreathable layer; and regulating the temperature proximate the damagedtissue with the circulated fluid.
 82. The method according to claim 81,further comprising alternating the temperature of the fluid betweentemperatures greater than the temperature proximate the damaged tissueand temperatures less than the temperature proximate the damaged tissue.83. The method according to claim 81, further comprising providing thefluid at a temperature greater than the temperature proximate thedamaged tissue.
 84. The method according to claim 81 further comprisingproviding the fluid at a temperature less than the temperature proximatethe damaged tissue.
 85. The method according to claim 81 furthercomprising distributing vacuum within the sealed environment through theporous pad.
 86. The method according to claim 81, wherein the fluid iswater.
 87. The method according to claim 81, further comprising:alternating the temperature of the fluid between temperatures greaterthan the temperature proximate the damaged tissue and temperatures lessthan the temperature proximate the damaged tissue; and distributingvacuum within the sealed environment through the porous pad.
 88. Themethod according to claim 81, further comprising: placing the breathablelayer in contact with the porous pad.
 89. The method according to claim81, further comprising: placing the breathable layer in contact with theporous pad; and covering the breathable layer and the porous pad with adrape to form the sealed environment.
 90. The method according to claim81, further comprising: covering the porous pad with a drape to form thesealed environment; and placing the breathable layer over the drape suchthat the drape is disposed between the porous pad and the breathablelayer.
 91. The method according to claim 90, wherein the drape has anadhesive.
 92. The method according to claim 91, further comprising:applying vacuum proximate the damaged tissue though the apertures. 93.The method according to claim 91, wherein the breathable layer has apair of flexible sheets connected to form the fluid channels between thesheets to receive the fluid, the pair of flexible sheets furtherincluding the apertures.
 94. The method according to claim 91, whereinthe pair of flexible sheets is connected by RF welds.
 95. The methodaccording to claim 91, wherein the fluid channels are continuous. 96.The method according to claim 91, wherein the fluid channels include aninlet configured for connection to a supply tube and an outletconfigured for connection to a drainage tube.
 97. The method accordingto claim 91 further comprising: regulating the temperature proximate thedamaged tissue with the circulated fluid based on an inflammatoryresponse of the damaged tissue.
 98. A method for controlling blood flowthrough damaged tissue, comprising: placing a porous pad proximate thedamaged tissue; placing a thermal control element in contact with theporous pad; covering the thermal control element and the porous pad witha drape; applying a vacuum to the porous pad; circulating a fluidthrough fluid channels in the thermal control element; and allowingmoisture transpiration proximate the damaged tissue through apertures inthe thermal control element.
 99. The method according to claim 98,further comprising: regulating the temperature proximate the damagedtissue with the circulated fluid.
 100. The method according to claim 98,wherein the thermal control element is at least one of a heating elementand a cooling element.